Bowel diseases and abnormal conditions, including particularly cancer of the lower bowel, have led to surgical operations commonly referred to as ileostomies or cholostomies in which a portion of the bowel is removed and the end of the remaining bowel is brought out through the patient's abdomen. The lower bowel may terminate at the surface of the abdominal skin, or, more commonly, may protrude slightly from the outer skin surface, with the bowel passing through the abdominal fascia, muscle, fat and skin layers. The end portion of the bowel extending to or through the skin is referred to as the stoma. Patients who have had such surgical operations commonly are provided with externally worn containers such as plastic bags, the bags having an opening that is adhesively sealed to the skin about the stoma. A short tube may be anchored at one end within the stoma with its outer end extending outwardly for attachment to a receptacle. The bowel is thus continually open to the flow of its contents through the stoma and into the bag. Such bags must be periodically removed and emptied, of course, and the adhesive seal of the mouth of the bag to the skin surrounding the stoma must be maintained airtight to prevent leakage and escape of odors. If disposable bags are used, means must be found for properly disposing of the bag with their contents. Further, the skin area surrounding the stoma must be maintained very clean, and irritations due to the adhesive seal between the skin and mouth of the bag must be avoided.
Depending largely upon the diet of the patient, the bowel contents issuing from the stoma is characterized by a soupy, water consistency, and the bowel contents may include particles of undigested or partially digested food, all of which must be permitted to escape from the stoma. Thus, it is desirable that the stoma be kept free of obstructions which might interfere with the flow of such bowel contents during periods of discharge.
Continent ostomy devices are devices which occlude the bowel at the stoma for some finite period of time, following which the bowel is emptied and again occluded to repeat the cycle. Patients having a surgically created ileal (Kock) pouch may tolerate occlusion for several hours before the bowel must be emptied. Many types of continent ostomy devices have been suggested for such patients and as an alternative to surgically created biological valves.
U.S. Pat. No. 4,381,765 describes an ileostomy valve which consists of a flexible drainage tube, one end of which is secured within the stoma by means of an inflatable balloon, and the other end of which is retained in a collapsibly folded position on a face-plate outside the stoma to form a leak-proof seal. The valve is opened and the bowel drained by simply releasing and unfolding the exterior end of the drainage tube.
In a preferred embodiment of the continent ostomy valve of U.S. Pat. No. 4,381,765, a wire bail and detachable clamp is utilized to maintain the tube in the folded, sealed configuration. One alternative embodiment utilizes a channel in the outer surface of the face-plate to receive the folded tube with finger like projections extending across the channel to hold the tube in place. Another alternative embodiment uses a hinged gate across the slot to restrain the tube.
An essential feature of the continent ostomy valves of U.S. Pat. No. 4,381,765 is that the valve is closed by folding and collapsing the external portion of the drainage tube. As the tube is released from the folded configuration to drain the bowel, care must be taken to keep the end of the tube pinched shut until ready for drainage to begin.
The physical dexterity required to unfold and refold the drainage tube in order to open and close the valve without inadvertently spilling discharged material has posed a problem for some elderly and physically impaired patients. It is accordingly an object of the present invention to provide an improved continent ostomy valve. It is a further object of the present invention to provide a continent ostomy valve which may be opened and closed with one hand. Is is a further object of the present invention to provide an improved continent ostomy valve having a compact design of low profile. These and other objects will be apparent from the ensuing description and claims.